Dermal Cooling System M1-TIP1-20

GUDID 00850019947991

Dermal Cooling System smooth tip

R2 DERMATOLOGY INC.

General cryosurgical system, thermo-electric cooler

• Primary Device ID: 00850019947991
• NIH Device Record Key: 6144ec3e-ca2b-4c0a-9071-56800a35c548
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dermal Cooling System
• Version Model Number: M1-TIP1-20
• Catalog Number: M1-TIP1-20
• Company DUNS: 080023734
• Company Name: R2 DERMATOLOGY INC.
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850019947564 [Primary]
GS1	00850019947861 [Primary]
GS1	00850019947991 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213294

FDA Product Code

• ILO: Pack, hot or cold, water circulating
• QPZ: Contact cooling for skin lesion pain relief

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09

On-Brand Devices [Dermal Cooling System]

• B563HP0030: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• B563HP0020: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• B563C20010: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• B563HP0050: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• B563HP0040: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• 00850019947182: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• 00850019947014: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• 00850019947007: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• 00850019947533: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• 00850019947045: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• 00850019947632: Dermal Cooling System dermabrasion tip
• 00850019947991: Dermal Cooling System smooth tip